FDA 510(k)

Dispositivo de Drenagem de Glaucoma AHMED ClearPath

Número K: K182518 · 2019-01-18

Data da decisão2019-01-18

Código do produtoKYF

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

AHMED ClearPath Glaucoma Drainage Device is the device name listed in this FDA 510(k) record. The listed applicant is New World Medical, Inc.. It received FDA 510(k) clearance on 2019-01-18 under 510(k) number K182518. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AHMED ClearPath Glaucoma Drainage Device?

AHMED ClearPath Glaucoma Drainage Device is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is New World Medical, Inc.. The 510(k) number is K182518.

When did AHMED ClearPath Glaucoma Drainage Device receive FDA 510(k) clearance?

AHMED ClearPath Glaucoma Drainage Device received FDA 510(k) clearance on 2019-01-18, under 510(k) number K182518.

Who is the listed applicant for AHMED ClearPath Glaucoma Drainage Device?

The FDA 510(k) record lists New World Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AHMED ClearPath Glaucoma Drainage Device?

The FDA product code for AHMED ClearPath Glaucoma Drainage Device is KYF.

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Outros registros que listam New World Medical, Inc. como candidato(a)

K243503VIA360™ Surgical System K220891Kahook Dual Blade Glide (KDB Glide)K231051Modelo FP8 da Válvula de Glaucoma Ahmed®K230975Modelo FP7 da Válvula de Glaucoma Ahmed®K211680Sistema cirúrgico Streamline K171451Modelo FP8 da Válvula de Glaucoma Ahmed

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Dispositivos Relacionados (Código: KYF)

K231051Modelo FP8 da Válvula de Glaucoma Ahmed®New World Medical, Inc.K230975Modelo FP7 da Válvula de Glaucoma Ahmed®New World Medical, Inc.K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation K171451Modelo FP8 da Válvula de Glaucoma AhmedNew World Medical, Inc.K161457Sistema de Tratamento de Glaucoma XENAllergan, Inc.K162060Válvula de Glaucoma AhmedNew World Medical, Inc.

Fonte oficial

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